Actively Recruiting
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Led by Hospices Civils de Lyon · Updated on 2026-01-15
30
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations. Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts. Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency. Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine. There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine. According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon. The study would aim to find the period of the day best correlated with 24h urinary copper excretion
CONDITIONS
Official Title
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Wilson's Disease (Leipzig score ≥4)
- Age between 6 and 70 years
- Able to perform 24-hour urine collection
- Currently treated with D-Penicillamine, Trientine, or Zinc
- No objection from patient or legal representative if minor
You will not qualify if you...
- Change in treatment within 6 months before inclusion
- History of liver transplantation
- Known chronic renal failure with GFR less than 30 ml/min
- On long-term diuretic or corticosteroid therapy
- Deprived of liberty by judicial or administrative decision
- Under judicial protection and unable to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
Bron, Rhone, France, 69500
Actively Recruiting
Research Team
E
Eduardo COUCHONNAL, Dr
CONTACT
A
Abdelouahed BELMALIH, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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